Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects

Exclusion Criteria

• -History of or ongoing, clinically significant, in the opinion of the investigator, visual disturbances including, but not limited to, visual hallucinations, migraine with visual symptoms, blurred vision, and frequent floaters/flashes associated with other symptoms such as dizziness at screening or Day -1
• -History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the investigator at screening or Day -1
• -Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening or Day -1 visit or expected during the conduct of the study
• -History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study noted at screening or Day -1
• -Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the investigator at screening or Day -1
• -History of any major surgical procedure within 30 days prior to the dose of study drug
• -Any clinically significant condition that may affect camizestrant absorption in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass), noted at screening or Day -1
• - Signs or confirmation of COVID-19 infection at screening or Day -1
• - Unable to refrain from or anticipates the use of:
• (a) Any drugs known to prolong QT interval or drugs associated with a known risk of Torsades de pointes within 4 weeks or 5 PK half-lives (whichever is longer) prior to the dose of study drug and throughout the study.
• (b) Use of any prescribed or non-prescribed medication
• (c) Any drug known to be moderate or strong inhibitors or inducers of CYP3A and/or P-gp, including St. John’s Wort, within 14 and 28 days, respectively, prior to the dose of study drug and throughout the study unless they are deemed acceptable following consultation with the sponsor medical monitor and the investigator.
• (d) Human immunodeficiency virus protease inhibitor, anticoagulant within 14 days prior to the dose of study drug and throughout the study.
• (e) Acetaminophen and ethacrynic acid within 24 hours prior to the dose of study drug and throughout the study.
• - Dosed in another clinical trial within 28 days or 5 half-lives (if known), whichever is longer, prior to the dose of study drug
• -Previous enrolment in the present study.
• -Any clinically significant abnormalities at screening or Day -1 on 12-lead ECG as judged by the investigator
• -Known history of hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant noted at screening or Day -1
• -Donation of blood > 500 mL or significant blood loss within 56 days prior to the dose of study drug
• - Plasma donation within 28 days prior to the dose of study drug.
• - Is working at or has an immediate family member (spouse or children) who works at the investigational site or is a sponsor staff directly involved with this study."
• - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)."
• - Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• -Participants with hepatic impairment are excluded from the study if any of the following criteria apply:
• • History or presence of drug abuse within the past 2 years prior to screening.
• • Positive results for the alcohol test and/or urine drug screen at screening or Day -1
• • Positive results at screening for hepatitis B surface antigen or HCV
• • Known history of HIV
• • Participant has evidence of hepatorenal syndrome or creatinine clearance < 60 mL/minute
• • History of unstable diabetes mellitus
• • Presence of transjugular intrahepatic portosystemic shunt."
• - Participants with normal hepatic function are excluded from the study if any of the following criteria apply:
• • History or presence of clinically significant thyroid disease
• • History or presence of alcoholism and/or drug abuse within the past 2 years prior to screening.
• • Positive results for the alcohol test and/or urine drug screen at screening or Day -1
• • Known history of HIV, positive results at screening for hepatitis B surface antigen or HCV.
• • Participant has creatinine clearance <80 mL/minute
• • Supine blood pressure < 90/40 mmHg or > 150/95 mmHg at screening or Day -1.
• • Supine pulse rate < 50 bpm or > 99 bpm at screening or Day -1.
• • Haemoglobin level below the lower limit of normal at screening or Day -1